Ignite Creation Date:
2025-12-24 @ 1:04 PM
Ignite Modification Date:
2026-02-25 @ 3:01 AM
Study NCT ID:
NCT03708861
Status:
WITHDRAWN
Last Update Posted:
2020-11-06
First Post:
2018-10-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetics of Maraviroc and Boosted Atazanavir Dual Regimen in Stable HIV-infected Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077592', 'term': 'Maraviroc'}, {'id': 'D000069446', 'term': 'Atazanavir Sulfate'}, {'id': 'D019438', 'term': 'Ritonavir'}], 'ancestors': [{'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D009842', 'term': 'Oligopeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2016-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-11-05', 'studyFirstSubmitDate': '2018-10-14', 'studyFirstSubmitQcDate': '2018-10-14', 'lastUpdatePostDateStruct': {'date': '2020-11-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'maraviroc (300 mg, QD) + atazanavir/ritonavir (200/100 mg, QD) pharmacokinetic evaluation', 'timeFrame': 'within the first 16 weeks after switch', 'description': 'Number of participants with maraviroc Ctrough\\>50ng/ml'}], 'secondaryOutcomes': [{'measure': 'viral suppression evaluation', 'timeFrame': 'week 60', 'description': 'Number of participants with HIV-RNA\\<20 cp/ml'}, {'measure': 'CD4 count evaluation', 'timeFrame': 'week 60', 'description': 'Changes in CD4+ count'}, {'measure': 'bone density evaluation', 'timeFrame': 'week 60', 'description': 'Changes in bone mineral density (DEXA femur and spine)'}, {'measure': 'bone metabolism markers evaluation', 'timeFrame': 'week 60', 'description': 'Changes in bone metabolism markers (bALP and vitamin D, PTH)'}, {'measure': 'glomerular and tubular renal function evaluation', 'timeFrame': 'week 60', 'description': 'Changes in proteinuria, glycosuria, phosphaturia and GFR;'}, {'measure': 'lipid metabolism markers evaluation', 'timeFrame': 'week 60', 'description': 'changes in total, HDL, LDL cholesterol and triglycerides'}, {'measure': 'bilirubin evaluation', 'timeFrame': 'week 60', 'description': 'changes in total bilirubin levels'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['maraviroc', 'atazanavir', 'ritonavir'], 'conditions': ['HIV Infection']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to describe pharmacokinetics of maraviroc (MVC) 300 mg and atazanavir/ritonavir (ATV/r) 200/100 mg QD in HIV-infected stable patients.', 'detailedDescription': 'The rational of this study is to save therapeutic options, toxicity and costs. The available literature shows that antiretroviral regimens that do not include a nucleoside backbone of tenofovir resulted in less bone and kidney toxicity. Atazanavir dosing 200/100 mg qd represents a simplification strategy correlated with virologic efficacy and a reduction of parameters toxicity associated. Maraviroc is suggested as a possible drug associated to PI/r in dual therapies. Even in this case, the available evidence supports the choice of the dosage of 300 mg/day.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age\\>18 years;\n* confirmed HIV-antibodies positivity;\n* signed informed consent;\n* HIV-RNA \\<20 cp/ml for the last 24 months;\n* no virological failures to PI regimens;\n* no major PI resistance associated mutations;\n* genotypic tropism for CCR5 co-receptor.\n\nExclusion Criteria:\n\n* active opportunistic infections or neoplasms;\n* need for drugs with known drug-drug interactions with included drugs;\n* liver cirrhosis;\n* any evidence of tropism for CXCR4 or dual infection;\n* pregnancy;\n* self-reported adherence\\<90%;\n* HBsAg positivity;\n* detectable HCV RNA.'}, 'identificationModule': {'nctId': 'NCT03708861', 'briefTitle': 'Pharmacokinetics of Maraviroc and Boosted Atazanavir Dual Regimen in Stable HIV-infected Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Turin, Italy'}, 'officialTitle': 'Pharmacokinetics of Maraviroc and Boosted Atazanavir Dual Regimen in Stable HIV-infected Patients', 'orgStudyIdInfo': {'id': 'MARAT'}, 'secondaryIdInfos': [{'id': '2014-004692-22', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MVC + ATV/r', 'description': 'maraviroc (300 mg tablet, 300 mg per day every 24 hours) + atazanavir/ritonavir (300 and 200 mg capsule, 300 and 200 mg per day every 24 hours / 100 mg capsule, 100 mg per day every 24 hours)', 'interventionNames': ['Drug: maraviroc (300 mg QD) + atazanavir/ritonavir (300 and 200 mg /100 mg QD)']}], 'interventions': [{'name': 'maraviroc (300 mg QD) + atazanavir/ritonavir (300 and 200 mg /100 mg QD)', 'type': 'DRUG', 'otherNames': ['CELSENTRI', 'REYATAZ', 'NORVIR'], 'description': 'Phase 1: switch from tenofovir disoproxil fumarate/emtricitabine (200/245 mg QD)+ atazanavir/ritonavir (300 /100 mg QD) to maraviroc (300 mg QD) + atazanavir/ritonavir (300 /100 mg QD).\n\nPhase 2: switch from maraviroc (300 mg QD) + atazanavir/ritonavir (300 /100 mg QD) to maraviroc (300 mg QD) + atazanavir/ritonavir (200 /100 mg QD)', 'armGroupLabels': ['MVC + ATV/r']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Torino', 'country': 'Italy', 'facility': 'University of Torino', 'geoPoint': {'lat': 44.88856, 'lon': 11.99138}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Turin, Italy', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Giovanni Di Perri', 'investigatorAffiliation': 'University of Turin, Italy'}}}}